TUXEDO-4

PHASE II STUDY OF TRASTUZUMAB-DERUXTECAN (T-DXd; DS-8201a) IN HER2-LOW BREAST CANCER PATIENTS PRESENTING WITH NEWLY DIAGNOSED OR PROGRESSING BRAIN METASTASES

CLINICAL TRIAL DETAILS

THE PRIMARY OBJECTIVE IS TO ASSESS THE OVERALL RESPONSE RATE (ORR) ACCORDING TO RANO-BM CRITERIA. THE STUDY WILL ALSO ASSESS THE ORR ACCORDING TO RECIST V.1.1 FOR EXTRACRANIAL AND OVERALL LESIONS, THE BICOMPARTMENTAL BENEFIT RATE (SUM OF THE COMPLETE RESPONSE, PARTIAL RESPONSE AND STABLE DISEASE RATES), DURATION OF RESPONSE, TIME TO RESPONSE, BEST PERCENTAGE CHANGE IN TUMOR BURDEN, PROGRESSION FREE SURVIVAL, OVERALL SURVIVAL, SAFETY, QUALITY OF LIFE, AND NEUROCOGNITIVE AND NEUROLOGICAL FUNCTION.

TUXEDO-4 AT CLINICALTRIALS.GOV

COUNTRY

STATUS

TUMOR TYPE

PHASE

SITES

Breast cancer with brain metastases

Spain, Austria

Recruitment

TRIAL OVERVIEW

PRESS RELEASE

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SCIENTIFIC IMPACT

SABCS 2024 poster

SABCS 2024 lay language summary

BLOG ARTICLES RELATED

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TRIAL SITES

Vall d'Hebron Instituto de Oncología (Spain) Hospital Beata María Ana (Spain) Hospital Universitario Clínico San Cecilio de Granada (Spain) Hospital Universitario Reina Sofía (Spain) Hospital Universitari Dexeus (Spain) Hospital Clínico Universitario de Valencia (Spain) Hospital Universitario Basurto (Spain) Hospital Universitario Ramón y Cajal (Spain) Hospital Universitario Virgen del Rocío (Spain) Hospital Universitario San Juan Alicante (Spain) Medical University of Vienna (Austria) Salzburg Cancer Research Institute-Center for Clinical Cancer and Immunology Trials (SCRI-CCCIT) (Austria)

Dr. Cortes and Dr. Llombart PHERain interview

Beyond Chemotherapy

Dr. Vanes Quiroga

Dr. Sofia Braga

Dr. Silvi Antolín

Dr. Escrivá de Romaní

Dr. Philipp Aftimos

Dr. Manuel Ruiz

Prof. Daniele Generali PHEGain interview

Dr. Jacques Medioni

Dr. Dunca Wheatley